Abstract: In accordance with one embodiment of the present disclosure, a prosthetic valve is provided. The prosthetic valve includes an annulus, a pair of leaflets, and a pair of support elements. The annulus has a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions. The pair of leaflets extend from the annulus and are separated from each other by the pair of support elements. The first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the annulus.

Abstract: Extracellular matrix (ECM) material conduits are disclosed. Methods for regenerating atrioventricular valves to replace defective atrioventricular valves within a heart of a subject using the ECM material conduits are also disclosed. Methods of sterilizing and decellularizing an ECM material are also disclosed.

Abstract: A heart valve prosthesis has a supported valve including a biological valve portion mounted within a support structure. The supported valve has inflow and outflow ends spaced axially apart from each other. A fixation support member includes an inflow portion that extends from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve. An outflow portion of the fixation support member extends from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member. The radially inner contact surface is attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve.

Abstract: Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

Abstract: Oxidation resistant bioprosthetic tissues and oxidation resistant bioprosthetic heart valve leaflets are described. Also provided are methods for preparing the oxidation resistant bioprosthetic tissues and bioprosthetic heart valve leaflets, and methods for preventing oxidative degeneration in bioprosthetic tissues, including immobilizing covalently an effective amount of an antioxidant to the bioprosthetic tissue.

Abstract: A method of preparing a tissue swatch comprising one or more desired thicknesses for use in the manufacture of a bioprosthetic device, said method comprising sectioning a sheet of frozen tissue to produce a tissue swatch of said one or more desired thicknesses.

Abstract: A prosthetic device for use in an anatomical orifice or lumen of a patient includes an expandable first stent structure coupled to a valve support structure having at least one leaflet. The stent structure includes a collar provided with at least one groove or opening adapted to engage a tab extending from the valve support structure. Rotation of the stent structure and valve support structure relative to one another assembles the prosthetic valve device. The prosthetic valve device may be used for sutureless treatment of various valvular conditions such as aorta stenosis and mitral valve replacement.

Abstract: A replacement heart valve device usable in a medical procedure in relation in heart valve replacement of a patient. In one embodiment, the replacement heart valve device includes a heart valve holder or conduit holder formed in the form of a cylindrical tube having a longitudinal cut substantially extending from one end to the other end of the cylindrical tube, and a conduit formed with a tubular segment of an elastic material. The conduit is mountable onto the heart valve holder or conduit holder or self-expanding stent. In one embodiment, at least a portion of the conduit is formed with a single layer of the elastic material. In another embodiment, at least a portion of the conduit is formed with two layers of the elastic material.

Abstract: A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

Abstract: A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

Abstract: A replacement heart valve and stitching method for reducing the unexpanded profile of the replacement heart valve are herein provided. The method includes whip stitching a plurality of leaflets together with a first whip stitch pattern a second whip stitch pattern which overlaps the first whip stitch pattern and is wound in an opposite direction. The method further involves securing the valve leaflets to one another via a running stitch.

Abstract: Extracellular matrix (ECM) valve conduits are disclosed. Methods for regenerating atrioventricular valves to replace defective atrioventricular valves within a heart of a subject using the ECM valve conduits are also disclosed. Methods of sterilizing and decellularizing an ECM material are also disclosed.

Abstract: Described is a heart valve leaflet manufactured from a mesh material. The mesh material may have an ability to capture circulatory/stationary/migratory cells of the body to become biologically active. In some cases, the mesh material is coated with a bioactive material, such as a molecule that binds to a cell adhesion molecule (CAM), a growth factor, an extracellular matrix molecule, a subendothelial extracellular matrix molecule or a peptide. The mesh has a stiffness that is comparable to a native heart valve leaflet, such that it functionally mimics a native heart valve.

Abstract: An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and/or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and/or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase.

Abstract: A two-piece prosthetic valve having first and second members, a first end of the first member being sized and configured to receive a second end of the second member therein, the second end of the second member being attached to the first member at at least one commissure connection point to form at least one leaflet therein.

Abstract: Bioprosthetic components based on, or comprising, biological materials for implants, preferably biological heart valves, in particular biological heart valve leaflets, which have only been chemically or thermally stabilized (partly crosslinked) at mechanically stressed points and therefore have zones having different mechanical properties, and to a method for the production thereof.

Abstract: One embodiment of the present invention provides an implantable valve prosthesis. The valve prosthesis includes a frame defining a lumen extending between a proximal frame end and a distal frame end along a longitudinal axis, and a first valve leaflet positioned within the lumen and having a distal edge attached to the frame and a proximal edge free of the frame. The first valve leaflet comprises a first and a second slit extend distally from the proximal edge and defining a free portion of the first valve leaflet between the first and second slits. The first valve leaflet is movable between a first position that allows fluid flow in a first, antegrade, direction and a second position that restricts flow in a second, retrograde direction.

Abstract: A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. The valve can have a multi-lobal shape in the unstressed position. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Abstract: A prosthetic heart valve assembly comprises a plurality of leaflets configured to replace the function of a native heart valve. Each leaflet comprises laminar pericardium tissue. Each leaflet has a coaptation edge formed by laser cutting. The tissue layers of each leaflet are fused together along an entire length of the coaptation edge, and tissue adjacent each coaptation edge does not have significant thermal energy damage.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Abstract: A valved conduit including a bioprosthetic valve, such as a heart valve, and a tubular conduit sealed with a bioresorbable material. The bioprosthetic heart valve includes prosthetic tissue that has been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve. The bioprosthetic heart valve may have separate bovine pericardial leaflets or a whole porcine valve. The sealed conduit includes a tubular matrix impregnated with a bioresorbable medium such as gelatin or collagen. The valved conduit is stored dry in packaging in which a desiccant pouch is supplied having a capacity for absorbing moisture within the packaging limited to avoid drying the bioprosthetic tissue out beyond a point where its ability to function in the bioprosthetic heart valve is compromised. The heart valve may be sewn within the sealed conduit or coupled thereto with a snap-fit connection.

Abstract: Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

Abstract: Biomaterials with enhanced properties such as improved strength, flexibility, durability and reduced thickness are useful in the fabrication of biomedical devices, particularly those subjected to continuous or non-continuous loads where repeated flexibility and long-term durability are required. These enhanced properties can be attributed to elevated levels of elastin, altered collagen types, and other biochemical changes which contribute to these enhanced properties. Examples of devices which would be improved by use of such tissue include heart valves, including percutaneous heart valves, and vascular grafts, patches and the like. Such enhanced materials can be sourced from specific populations of animals, such as neonatal calves, or in range-fed adult cattle, or can be fabricated or created from cell populations exhibiting such properties.

Abstract: A valve prosthesis, such as an artificial venous valve, is described. The valve prosthesis has a support frame formed from a cannula and an attached covering that defines an opening adapted to move between a first position in which the opening is open to fluid flow and a second position in which the opening is closed to fluid flow. The support frame includes a leaflet support portion and a circumferential centering support element disposed adjacent the leaflet support portion with respect to a lengthwise axis of the support frame and mirroring the leaflet support portion with respect to a transverse axis of the support frame.

Abstract: A method of assembling a prosthetic valve using sheets of material, such as pericardium material, polymer or bioengineered film, or other material. The method provides an accurate and repeatable system of making pericardial valves in which sheets or pieces of material are held securely in place relative to each other throughout the steps of assembling the valve. In addition, methods of the present invention include maintaining consistent alignment of the fixtures and pericardium material throughout the valve assembly process and utilize features that make the tooling components easy to assemble and handle. Certain aspects of the invention can be used to help establish a repeatable sewing and cutting technique for creating a pattern shape for valve leaflets, establishing stitch lengths, and determining the exact placement of stitches.

Abstract: Improved methods for heart valve replacement surgery are described. The methods utilize an allograft comprising a layer of amnion to improve the performance and reduce complications of heart valve replacement surgery and the allograft has a pre-made size and shape suitable for the application.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: This document provides methods and materials related to providing a mammal with a replacement valve (e.g., a synthetic or artificial heart valve). For example, synthetic or artificial heart valve that can be delivered in a minimally invasive manner are provided.

Abstract: A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Abstract: A replacement heart valve and stitching method for reducing the unexpanded profile of the replacement heart valve are herein provided. The method includes whip stitching a plurality of leaflets together with a first whip stitch pattern a second whip stitch pattern which overlaps the first whip stitch pattern and is wound in an opposite direction. The method further involves securing the valve leaflets to one another via a running stitch.

Abstract: A method for treating glutardialdehyde-stabilized biological tissue of animal or human origin, such as porcine, bovine pericardium or human cadaver heart valves, provides a physical plasma treatment of the, in particular, collagen tissue for increasing the biocompatibility, cell colonization and durability thereof.

Abstract: A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Abstract: A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. The valve can have a multi-lobal shape in the unstressed position. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Abstract: The present invention relates to an assembly comprising: a ring having anchoring elements for attaching the ring in a passage surrounded by body tissue, in particular blood vessel tissue. An applicator for fitting the ring in the passage; in which the anchoring elements have an anchoring position in which they protrude with respect to the ring, and in which the anchoring elements comprise a memory material, such as a memory metal or memory polymer, and are designed so that they can be bent from an anchoring position counter to a spring force into a fitting position and can be frozen in this fitting position by a temperature treatment in order to bend the anchoring elements back from the fitting position by the effect of this spring force into the anchoring position when a predetermined threshold temperature is exceeded, and in which the applicator is provided distally with a carrier for carrying the ring.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive device may include a biodegradable material that biodegrades to offset flow changes caused by tissue ingrowth. The inventive device may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits.

Abstract: A prosthetic heart valve implantable by catheter without surgery includes a substantially “dry” membrane or tissue material. In at least one embodiment, the tissue is folded in a dry state to form a tissue leaflet assembly that is then attached to a frame to form an implantable prosthetic heart valve. Alternatively, one or more tissue leaflets are operatively associated with a frame to form an implantable prosthetic heart valve. The implantable prosthetic heart valve is subsequently pre-mounted on an integrated catheter delivery system. The catheter delivery system that includes the implantable prosthetic heart valve is then packaged and transported while the tissue remains dry. The implantable prosthetic heart valve, while remaining substantially dry, can then be implanted into the receiving patient.

Abstract: An invasive cardiac valve comprises a tubular stent (1) and a valve (2). One end of the tubular stent (1) is of a frusto-conical structure, the other end is wide open, and the diameter of the open end is greater than the diameter of the frusto-conical end. The valve (2) is attached to the frusto-conical end of the tubular stent (1); and a delivery and retrieval hole (4) of the cardiac valve is provided at the top of the open end of the tubular stent (1). Because the diameter of the open end is greater than the diameter of the frusto-conical end, the cardiac valve can be effectively fixed in a position of aortic annulus to prevent the cardiac valve displacement caused by the impact of the blood flow. Because the valve (2) is attached to the frusto-conical end of the tubular stent (1), the valve (2) can totally avoid the left and right coronary ostia and does not affect the haemodynamics of the coronary artery.

Abstract: A method of assembling a prosthetic valve using sheets of material, such as pericardium material, polymer or bioengineered film, or other material. The method provides an accurate and repeatable system of making pericardial valves in which sheets or pieces of material are held securely in place relative to each other throughout the steps of assembling the valve. In addition, methods of the present invention include maintaining consistent alignment of the fixtures and pericardium material throughout the valve assembly process and utilize features that make the tooling components easy to assemble and handle. Certain aspects of the invention can be used to help establish a repeatable sewing and cutting technique for creating a pattern shape for valve leaflets, establishing stitch lengths, and determining the exact placement of stitches.

Abstract: Composite leaflets and prosthetic valves incorporating the same are disclosed. An illustrative composite leaflet includes a flexible inner region, which is formed with a synthetic polymeric material, and a flexible peripheral region, which is formed with a remodelable material effective to promote tissue ingrowth. The peripheral region extends from at least a portion of the flexible inner region and is configured to contact a wall of a tubular body passage and thereby promote tissue ingrowth into the peripheral region from the wall of the tubular body passage.

Abstract: A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Abstract: A method of implanting a prosthetic mitral valve assembly is disclosed. The prosthetic mitral valve assembly includes a stent and valve combination. The prosthetic mitral valve assembly is provided with an anchoring portion adapted to be positioned in the left atrium. In one embodiment, the anchoring portion includes at least one anchoring arm sized for placement in a pulmonary vein. The stent is radially expandable so that it can expand into position against the walls of the left atrium and accommodate a wide range of anatomies. Contact between the stent and the native tissue in the left atrium reduces paravalvular leakage and prevents migration of the stent once in place.

Abstract: A transcatheter, percutaneously implantable, prosthetic heart valve is provided that comprises a lattice frame and two or more integrated cusp and leaflet folded structures attached to the lattice frame. The two or more integrated cusp and leaflet folded structures each comprise a flat sheet of biocompatible membrane that is folded to include a substantially conical shape according to a flat folding pattern. The substantially conical shape is further formed by joining apposing sides of the substantially conical shape along a seam. The two or more integrated cusp and leaflet folded structures are each attached along their respective seams to the lattice frame in a direction substantially parallel to an axis of the lattice frame. Embodiments of valves described herein have application within the entire vascular system.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: Described are percutaneous vascular valves free of attached support structures and deployment systems and methods for providing attachment of the valves within a vascular vessel.

Abstract: This invention relates to processes of preparing heterogeneous graft material from animal tissue. Specifically, the invention relates to the preparation of animal tissue, in which the tissue is cleaned and chemically cross-linked using both vaporized and liquid cross-linking agents, resulting in improved physical properties such as thin tissue and lowered antigenicity, thereby increasing the ease of delivering the tissue during surgery and decreasing the risk of post-surgical complication, respectively.

Abstract: Biomaterials with enhanced properties such as improved strength, flexibility, durability and reduced thickness are useful in the fabrication of biomedical devices, particularly those subjected to continuous or non-continuous loads where repeated flexibility and long-term durability are required. These enhanced properties can be attributed to elevated levels of elastin, altered collagen types, and other biochemical changes which contribute to these enhanced properties. Examples of devices which would be improved by use of such tissue include heart valves, including percutaneous heart valves, and vascular grafts, patches and the like. Such enhanced materials can be sourced from specific populations of animals, such as neonatal calves, or in range-fed adult cattle, or can be fabricated or created from cell populations exhibiting such properties.

Abstract: A prosthetic heart valve assembly comprises a plurality of leaflets configured to replace the function of a native heart valve. Each leaflet comprises laminar pericardium tissue. Each leaflet has a coaptation edge formed by laser cutting. The tissue layers of each leaflet are fused together along an entire length of the coaptation edge, and tissue adjacent each coaptation edge does not have significant thermal energy damage.

Abstract: A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

Abstract: A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.